Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments
Primary Purpose
Mild Cognitive Impairment, So Stated
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stimulation
SHAM
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment, So Stated focused on measuring mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, memory, memory consolidation
Eligibility Criteria
Inclusion Criteria:
amnestic and amnestic plus MCI-patients:
- Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
- Objective evidence of memory impairment; additional cognitive domains may be affected as well;
- Preservation of independence in functional abilities
- no dementia
- age: 50-90 years
Exclusion Criteria:
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- dementia
- contraindications to MRI
Sites / Locations
- Charite CCM Neurologie Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
0,75 Hz stimulation
SHAM stimulation
Arm Description
slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
SHAM stimulation during periods of Slow Wave Sleep
Outcomes
Primary Outcome Measures
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
Secondary Outcome Measures
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.
Spindel activity during sleep indicated via several spindel parameters like number, duration, frequency of spindles; compared between 0,75 Hz and SHAM stimulation during SWS.
Neuronal correlates (EEG-power in slow oscillation frequency bands induced by 0,75 Hz vs SHAM stimulation during SWS; EEG-correlates of encoding and retrieval of a declarative memory task).
Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
Full Information
NCT ID
NCT01782391
First Posted
June 5, 2012
Last Updated
May 20, 2021
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01782391
Brief Title
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments
Official Title
Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of appropriate participants
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, So Stated
Keywords
mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, memory, memory consolidation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0,75 Hz stimulation
Arm Type
Experimental
Arm Description
slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
Arm Title
SHAM stimulation
Arm Type
Sham Comparator
Arm Description
SHAM stimulation during periods of Slow Wave Sleep
Intervention Type
Device
Intervention Name(s)
Stimulation
Other Intervention Name(s)
oscillating direct current brain stimulation
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
no stimulation
Primary Outcome Measure Information:
Title
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Description
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Description
Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.
Spindel activity during sleep indicated via several spindel parameters like number, duration, frequency of spindles; compared between 0,75 Hz and SHAM stimulation during SWS.
Neuronal correlates (EEG-power in slow oscillation frequency bands induced by 0,75 Hz vs SHAM stimulation during SWS; EEG-correlates of encoding and retrieval of a declarative memory task).
Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
amnestic and amnestic plus MCI-patients:
Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
Objective evidence of memory impairment; additional cognitive domains may be affected as well;
Preservation of independence in functional abilities
no dementia
age: 50-90 years
Exclusion Criteria:
untreated severe internal or psychiatric diseases
epilepsy
other severe neurological diseases eg., previous major stroke, brain tumour
dementia
contraindications to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, Professor
Organizational Affiliation
Charite Universitätsmedizin Berlin - Neurologie
Official's Role
Study Chair
Facility Information:
Facility Name
Charite CCM Neurologie Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18977813
Citation
Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC, Fregni F. Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):444-7. doi: 10.1136/jnnp.2007.141853. Epub 2008 Oct 31.
Results Reference
background
PubMed Identifier
17086200
Citation
Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
Results Reference
background
PubMed Identifier
20046194
Citation
Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
Results Reference
background
PubMed Identifier
18525028
Citation
Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
Results Reference
background
PubMed Identifier
21531243
Citation
Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
Results Reference
background
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Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments
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